FDA Moves to Stop Subpar KN95 Respirators from Being Sold in the U.S.

The Food and Drug Administration (FDA) is warning health care workers and other medical first responders about defective KN95 respirators imported from China for failing to meet a minimum particulate filtration efficiency of 95 percent in National Institute for Occupational Safety and Health (NIOSH) testing. This move is a part of the broader effort by the FDA to combat the sale of fraudulent COVID-19 products.

The FDA first allowed the import of Chinese-made KN95 respirators on April 3, 2020, by issuing an emergency use authorization (EUA), in response to continued respirator shortages during the early days of the COVID-19 pandemic. The KN95 respirators were supposed to provide similar levels of protection as NIOSH-approved respirators, such as the N95. The FDA defines N95 and KN95 respirators as a protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. Respirators provide a higher level of protection than the more common surgical mask, which is a loose-fitting device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. The FDA regulates respirators and surgical masks differently based on their intended use.

The FDA published a list of 85 approved manufacturers, which it later reduced to 14 in May 2020, because of concerns that some KN95 respirators failed to meet the expected filtration performance efficiency. Health and Human Services Secretary Alex Azar recently appeared on Fox Business’s “Mornings with Maria,” to discuss the FDA’s move to stop subpar respirators from being sold in the U.S. “What we found, though, was that on inspection, some of the manufacturers were not reliable and they had not actually gotten that independent test verification [required under the EUA],” Azar said. “FDA quickly removed those products from the market.” The FDA now publishes a list of respirators no longer authorized to be sold pursuant to the EUA. The remaining Chinese-made KN95 respirators that demonstrated at least 95 percent filtration efficiency remain authorized for emergency use as respirators.


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